More MS news articles for August 2002

Current Clinical Trials in MS

http://www.epva.org/MSQR_Archive/Spring02_6.htm

Clinical Trials Open for Enrollment
MSQR - V21.  N1.   Spring  2002

AndroGel® (Testosterone Gel) Study

Location: Joint study of UCLA MS Research Center and Harbor UCLA, Los Angeles, CA
Purpose: Open-label study to determine whether treatment with testosterone causes any harmful side effects not related to MS and to obtain information concerning the effectiveness of testosterone treatment in men with MS.
Eligibility: 12 male subjects
Procedures: Screening visits followed by 6-month pre-treatment phase, 12-month treatment phase, and an exit visit. Monthly magnetic resonance imaging (MRI) as well as visits every 3 months to monitor condition. Visits will be made to both facilities during the course of the study.
Benefit: Frequent, careful monitoring of medical condition. Participants may or may not benefit from taking the testosterone.
For Information: Contact Ricki Klutch at the UCLA MS Research Center at (310) 825-7313, or via e-mail: rklutch @ ucla.edu.

Antegren® (Natalizumab) Phase III Trial for RRMS

Location: International multi-centers in the US, Canada, Europe, South America
Purpose: To determine the effectiveness in reducing the rate of clinical relapses in MS, in slowing the progression of disability associated with MS, and in attenuating the number of brain lesions viewed on repeat MRI scans.
Eligibility: Women and men between the ages of 18 and 50 who have a diagnosis of relapsing-remitting MS and have experienced at least one medically documented relapse within 12 months prior to starting the study. Participants must not have taken Avonex®, Betaseron®, or Copaxone® for 6 months previous to study enrollment.
Procedures: Participants will receive intravenous infusions of either the study drug or placebo every 4 weeks for approximately 2 years. Two-thirds of study participants will receive study medication, one-third will receive placebo. Participants will undergo three MRIs during the study.
Benefit: This phase III trial may lead to a new FDA-approved therapy that enhances the quality of life of persons with MS.
For Information: There are over 100 centers in this study, including a great many in the US. Thus, please contact the center(s) in your area to determine their involvement in this study and your possible participation at that site.

Antibiotic Treatment Directed Against Chlamydia Pneumonia

Location: University of Texas Southwestern Medical Center, Dallas, TX
Purpose: To see if treatment with antibiotics in CSF chlamydia positive individuals with MS will decrease lesion burden on MRI.
Eligibility: Participants must have clinically definite MS with EDSS scores between 1.0 and 3.5, age between 19 and 65, evidence of C. pneumonia infection in CSF by satisfying at least one of two criteria (positive CSF by PCR for C. pneumonia MOMP gene or antibody titer at least 2.5 times greater than background or positive culture), two enhancing lesions on MRI, no allergy to azithromycin and rifampin, not pregnant or lactating, adequate renal function (creatinine < 1.4 mg/dl), normal hepatic function, no relapses within 90 days or steroids within 30 days.
Procedures: Participants will undergo lumbar puncture, screening MRI, venous blood draws, repeat lumbar puncture and MRIs during trial.
Benefit: This study may result in a decrease in lesions and relapses as well as a decrease in disability.
For Information: Contact Dr. Kathleen Hawker at the University of Texas Southwestern Medical Center at (214) 648-9030.

Calpain Activation of T Cells in Demyelinating Disease

Location: Medical University of South Carolina (MUSC), Charleston, SC
Purpose: To determine if beta-interferon has an effect on the cellular expression of calpain, an enzyme believed to be involved in the pathogenesis of MS.
Eligibility: Participants must have a diagnosis of definite relapsing-remitting MS, be eligible for therapy with beta-interferon but not yet started on treatment, and be able to travel to Charleston monthly for a 6-month period including any relapses during this time.
Procedures: Blood will be collected at various time points before and after the initiation of beta-interferon for calpain measurement from T cells. Each study participant will be followed for 6 months.
Benefit: Participants will help to determine the mechanisms of demyelination in MS.
For Information: Contact the MS Center at MUSC at (843) 792-3221.

Cannabinoids as a Therapy for Spasticity in MS

Location: Multi-centers in England
Purpose: To determine whether cannabinoids have a beneficial therapeutic effect on spasticity in MS, and also beneficial effects on pain, tremor, urination disturbance, and overall measures of quality of life.
Eligibility: Patients with clinically definite or laboratory supported MS, aged 18 to 64 years, significant spasticity in at least two leg muscle groups, stable disease for last 6 months, and anti-spasticity medication and PT stabilized for the last 30 days. Must reside within travel distance of participating center. There are also exclusion criteria.
Procedures: Participants in the double blind, three-way controlled trial will be assigned to one of four regimens:
delta 9-tetrahydracannabinol (THC), placebo capsules matching appearance of THC, natural cannabis oil (Cannador) containing same dose of THC and made up to GMP standard, or placebo capsules matching appearance of the cannabis capsules. Patients to attend a total of 7 visits within the main 15-week trial, during which assessments of spasticity and mobility will be made and side effects will be recorded. Participants will be adjusted on their optimal current therapy before trial entry, then undergo a 5-week titration phase and an 8-week maintenance phase before drug withdrawal. Assessments of quality of life and disability will be made by mail questionnaire.
Benefit: This study may lead to a treatment for spasticity.
For Information: Contact Dr. J. P. Zajicek at Derriford Hospital in Plymouth, England, via e-mail: john.zajicek @ phnt.swest.nhs.uk, or via telephone at 011 + 44 + 01752 + 315252.

Cognitive Impairment Investigational Drug

Location: Multi-centers in the USA
Purpose: This study will investigate whether a drug shown to improve cognition in persons with Alzheimer’s disease will also improve cognition in MS. The drug being studied is currently approved only for the treatment of mild to moderate dementia of the Alzheimer’s type. For regulatory reasons, the names of the drug and sponsor have not been released.
Eligibility: Women and men aged 25 to 60 years with all forms of MS, who have significant memory impairment. To complete the comprehensive neuropsychological and cognitive tests involved in the study, all subjects must be fluent in English, and a caregiver or family member must accompany the participant on all study visits.
Procedure: After screening (possibly including MRI) to ascertain eligibility for the trial, participants will receive daily oral medication or inactive placebo for 12 weeks. Subjects will have a 50/50 chance of receiving study medication or placebo during the study. Safety and clinical assessments will be conducted at clinical visits every 3 weeks during the trial, for a total of 4 visits once treatment begins. Procedures to evaluate safety include blood tests, electrocardiograms (a tracing of the electrical activity of the heart), physical exams, and vital signs. Treatment effects will be evaluated based on differences between the treated and placebo subjects on a variety of memory and other cognitive and neuropsychological tests and scales.
Benefit: This study may lead to a new treatment for cognitive impairment in MS.
For Information: Please call the following toll-free number for a list of the approximately 20 U.S. clinical centers that are participating: (866) 812-8547.

High-Dose Cyclophosphamide and Total Body Irradiation with T Lymphocyte-Depleted
Autologous Peripheral Blood Stem Cell or Bone Marrow Rescue

Location: Northwestern Memorial Hospital, Chicago, IL and Rush-Presbyterian-St. Luke’s Medical Center, Chicago, IL
Purpose: Determine the efficacy, in terms of disease progression, of high-dose cyclophosphamide and total body irradiation with T lymphocyte-depleted autologous peripheral blood stem cell or bone marrow rescue in MS.
Eligibility: Male and female patient up to 59 years of age, diagnosis of MS, Kurtzke score of 4.0 to 7.5 with increase of 1.0 point over the past 12 months, more than 3 relapses in 24 months despite conventional disease-modifying therapy, failure to stabilize active clinical progression with a 3-day regimen of methylprednisolone.
Procedure: Following an induction course of cyclophosphamide IV, patients receive filgrastim (G-CSF) subcutaneously (SC) daily until the completion of peripheral blood stem cell (PBSC) harvesting over several days. Patients who do not mobilize sufficient cells undergo bone marrow harvest. Harvested PBSCs or bone marrow then undergo T lymphocyte depletion. Receive cyclophosphmide IV over 1 hour on days –6 and –5 and methylprednisolone IV daily days –4 to –1. Undergo total body irradiation twice a day on days –4 to –1. Lymphocyte-depleted PBSCs or bone marrow is reinfused on day 0. Receive G-CSF SC daily beginning on day 0 and continue until blood counts have recovered for 3 days. Patients are followed at 1, 2, 3, 6, and 12 months and then annually for 5 years.
Benefit: This Phase I study may ultimately lead to a new treatment for MS.
For Information: At Northwestern, contact Ann Traynor at
(312) 908-5284 and at Rush-Presbyterian-St. Luke’s, call Floyd Davis at (312) 942-5000.

Molecular Analysis of the IG Repertoire

Location: University of Texas Southwestern Medical Center, Dallas, TX
Purpose: This study will explore the role of B cells in the pathogenesis of MS.
Eligibility: Participants must have clinically definite MS.
Procedures: Participants will undergo venous blood draw and lumbar puncture once a year for
3 years.
Benefit: This research may lead to new therapies in MS. Participants will be compensated for their annual blood draw and lumbar puncture.
For Information: Contact Dr. Nancy Monson at the University of Texas Southwestern Medical Center in Dallas at (214) 648-9030, or via e-mail: nancy.monson @ utsouthwestern.edu.

MRI to Evaluate MS Activity

Location: National study sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), based in Bethesda, MD
Purpose: To identify immunological processes that may contribute to the development of MS and to design specific therapies for the disease. The effect of interferon beta-1b will be studied for its effect on RRMS disease activity as measured by MRI.
Eligibility: Men and women with laboratory supported definite MS or a relapsing-remitting course.
Procedures: Monitor MS disease activity over time via MRI with gadolinium. MRI findings will be correlated with clinical status. Some patients will also be studied by magnetization transfer (MT), along with MRI in an effort to identify the metabolic changes occurring in acute lesions of MS. MRI. Immunological studies will be done in parallel with the MRI evaluation.
Benefit: Improve efforts to measure progression of MS, identify immunological processes that contribute to the disease and design specific therapies.
For Information: Contact the NIH Patient Recruitment and Public Liaison Office via toll-free telephone at (800) 411-1222, or via e-mail: prpl @ mail.cc.nih.gov.

Novantrone® and Avonex® (Interferon Beta-1a) or Novantrone® and Copaxone® (Glatiramer Acetate)

Location: University of Maryland in Baltimore, MD; Cleveland Clinic, Cleveland, OH; Mt. Sinai School of Medicine in New York, NY; and Yale MS Research Center in New Haven, CT
Purpose: Open-label study to determine tolerability of combining Novantrone with either Avonex or Copaxone
Eligibility: Participants must be suboptimal responders to Avonex or Copaxone and have worsening relapsing-remitting or secondary progressive MS.
Procedures: Clinical examinations, blood samples, and MRI scans.
Benefit: To gain knowledge on tolerability of combination therapies that have the potential (unproven) to improve response to single-agent disease modifying therapy.
For Information: Contact the participating Center nearest to you:
Baltimore, MD: (410) 328-5605
Cleveland, OH: (216) 444-6800 or (800) 223-2273
New Haven, CT: (203) 764-4285
New York, NY: (212) 241-4264

Novantrone® Safety, Quality of Life, and Cost of Illness Study

Location: Multi-centers in the US.
Purpose: To study the long-term safety of Novantrone (mitoxantrone) and to evaluate the relationship between disease activity, progression of disability or progression of handicap and quality of life and disease-related costs among patients who participate in the Novantrone Safety Study.
Eligibility: Participants must have secondary progressive, progressive-relapsing, or worsening relapsing-remitting MS; must be 18 to 65 years of age, have normal WBC and platelet count; and not have any significant heart disease or severe infection.
Procedure: All participants will receive standard Novantrone (mitoxantrone) therapy, including 12 mg/m sq of mitoxantrone IV every 3 months for 3 years, must have blood draw and urinalysis every 3 months, must have echocardiogram (ultrasound of the heart) at outset and every 3 months in the last year of the 3-year therapy and after therapy completed. The study is 3 years of treatment followed by 2 years of follow-up of potential adverse effects, for a total of 5 years. Participation does not preclude other treatments for MS during the trial.
Participants also will be asked to complete a survey every 3 months with questions about their disability status, fatigue, pain, and other quality of life measures. In addition, also every 3 months, they will be asked to record in a diary their MS-related symptoms and the various costs incurred due to MS.
Benefit: Treatment with Novantrone may improve or stabilize the patient’s MS. There is no direct benefit to participants in the quality and cost portion of this project. However, this aspect of the research study will help to acquire more knowledge about the quality of life and the cost of disease for patients with multiple sclerosis who are treated with Novantrone.
For Information: Contact RENEW Help Desk toll-free at (866) 736-3910, or Debbie Ruotolo at the Yale MS Research Center NARCOMS Project at (203) 932-5711, ext. 5544, or via e-mail: Debbie.Ruotolo @ yale.edu. Debbie will refer interested persons to the nearest participating center.

Rolipram to Treat RRMS and SPMS

Location: National study sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) based in Bethesda, MD
Purpose: To evaluate the safety, tolerability, and effect of Rolipram on MS and to examine whether Rolipram can dampen the part of the immune response believed to lead to MS and reduce disease activity.
Eligibility:
• Male and female between the ages of 18 and 65 years
• Clinically definite relapsing-remitting or secondary progressive MS
• EDSS score between 4.0 and 6.5 for stage I and between 1.5 and 6.5 for stage II
• Must have either failed standard treatment (interferon beta, glatiramer acetate) by clinical measures, not been eligible for any standard treatments available or opted not to start/continue these treatments
• Must have an average of up to 2 Gd-enhancing lesions per month over the 3 month pre-treatment baseline period for stage I and an average of at least 0.5 Gd-enhancing lesions per month over the 4-month pre-treatment period for stage II
• Must not have had a relapse during 30 days before initiation of treatment.
Procedures: Candidates will be screened with a complete neurological and medical evaluation. During the 3-month baseline period, approximately 4 MRI scans will be obtained and participants with MS activity above a certain level will continue with the treatment phase.
During the 8-month treatment phase, participants will take Rolipram tablets in increasing doses for the first month until their individual maximum tolerated dose is established, which will continue at that level for the rest of the treatment phase. Monthly clinic visits required for examination and MRI scans. Following the treatment phase, monthly exams and MRIs will be required for 3 months. Some of the evaluations will include drawing blood and collecting urine. Lumbar puncture (spinal tap) and leukapheresis each will be done twice.
Benefit: May lead to a new treatment for RRMS and SPMS.
For Information: Contact the NIH Patient Recruitment and Public Liaison Office via toll-free telephone at (800) 411-1222, or via e-mail: prpl @ mail.cc.nih.gov.

Schwann Cell Transplantation as a Reparative Therapy for MS

Location: Yale MS Research Center, New Haven, CT
Purpose: To test the potential of Schwann cells as a replacement of myelin in MS plaques.
Eligibility: Male and female patients with advanced MS; must live within 100 miles of New Haven.
Procedures: This Phase I study requires a small number of test subjects (up to five). Schwann cells will be isolated from a piece of the participant’s own nerve cell (sural nerve biopsy) and then implanted into the brain.
Benefit: This is a Phase I study, a first step in development of myelin repair treatment. The study will not lead to improvement of function.
For Information: Contact Dr. Jana Preiningerova at the Yale MS Research Center, (203) 764-4291, or via e-mail: Jana.Preiningerova@yale.edu.

Total-Body Irradiation, Anti-Thymocyte Globulin and Cyclophosphamide Followed by Syngeneic or Autologous Peripheral Blood Stem Cell Transplantation in Patients With MS

Location: Multiple locations in the US; based in Seattle, WA
Purpose: Phase I pilot study to:
• Determine the toxicity of total-body irradiation, anti-thymocyte globulin, and cyclophosphamide followed by syngeneic or autologous blood stem cell (PBSC) transplantation in patients with MS
• Determine the disease response of patients treated with this regimen
• Determine the safety and efficacy of filgrastim (G-CSF) for PBSC mobilization in this population.
Eligibility:
• Men and women aged 18 to 60 years
• Diagnosis of rapidly progressive MS by Poser criteria and at high risk for a fatal outcome or severe disability with one of the following: primary progressive disease, relapsing-remitting disease with two or more attacks in 2 years, secondary progressive disease
• EDSS between 5.0 and 8.0 with deterioration in the EDSS of 1 or more points over the past year
• More than 60 days since relapse of MS
• Sibling donor proven to be an identical twin by ABO typing, HLA typing, and VNTR analysis (for syngeneic transplantation)
Procedures: Patients receive oral prednisone on days 0 to 10. Beginning on day 1, undergo autologous PBSC transplantation and receive G-CSF subcutaneously daily until leukapheresis is completed. Leukapheresis begins on approximately day 4 and continues until adequate CD34+PBSC are collected. PBSC are collected from syngeneic donors in a similar manner. Patients undergo total body irradiation twice daily on days –5 and –4. Patients receive cyclophosphamide IV on days –3 and –2 and anti-thymocyte globulin IV on days –5, –3, –1, 1, 3, and 5. Patients undergo autologous or syngeneic PBSC transplantation on day 0. Following PBSC transplantation, receive oral prednisone on days 7 to 30 and G-CSF IV daily beginning on day 0 and continuing until blood counts recover. Patients are followed at 30, 80, and 90 days, monthly for 6 months, and then at 1 and 2 years.
Benefit: This study may lead to a new treatment for progressive MS.
For Information: Contact Richard Nash at the Fred Hutchinson Cancer Research Center in Seattle, WA, at (206) 667-4978.

Utility of Automated Neuropsychological Assessment for Evaluation of Cognitive Dysfunction and Assessment of Cognition in RRMS Treated With Avonex®

Location: University of Virginia, Charlottesville, VA
Purpose: To compare results from an automated battery of neuropsychological measures with traditional neuropsychological paper/pencil tests; to assess correlation between physical symptoms (EDSS scores) and cognitive symptoms in patients on Avonex, as well as cognition over time in patients on Avonex and in controls.
Eligibility: Men and women ages 18 to 60 with diagnosis of relapsing-remitting MS, initiating therapy with Avonex, and an EDSS between 1.0 and 5.5. There are exclusion criteria, which will apply to both groups.
Procedures: Participants will be evaluated five times over 2 years at 6-month intervals. Patients with MS must have first evaluation before initiating Avonex, and will have brief physical assessment at each visit. Testing takes about 3 hours and looks at areas of memory, mental processing speed, attention, and executive functioning. No normal treatments will be omitted and patients can be treated for exacerbations.
Benefit: Participants will be paid for completed visits.
For Information: Contact Lorie Elder at the University of Virginia School of Medicine Clinical Trials Office via telephone at (434) 924-8530, or via e-mail: uvaclintrials @ virginia.edu.

Zenapax® to Treat MS

Location: National study sponsored by the NINDS in Bethesda, MD
Purpose: To examine the safety and effectiveness of Zenapax
(a laboratory-manufactured antibody) in treating MS.
Eligibility:
• Women and men aged 18 to 65 years
• Persons with relapsing-remitting or secondary progressive MS who have had more than one relapse within 18 months preceding study enrollment
• EDSS score between 2.5 and 6.5, inclusive
• Have failed standard IFN-beta therapy
• Must have at least 2 Gd-enhancing lesions or greater in the three pre-treatment MRI scans (an average of at least 0.67 Gd-enhancing lesions/scan)
Procedures: Three MRI scans over initial 2 months to evaluate disease activity. During treatment, receive seven IV infusions of Zenapax––the first two will be given 2 weeks apart; the next five will be given once a month. Before each infusion, participants will have two MRI scans, one using standard procedure and one using gadolinium. Blood and urine samples will be taken at each visit. There will be skin tests. A lumbar puncture will be done at the beginning and at end of the treatment phase. Lymphocytes will be collected before, during, and after treatment.
Benefit: May lead to a new treatment for RRMS or SPMS.
For Information: Contact the NIH Patient Recruitment and Public Liaison Office, via toll-free telephone at (800) 411-1222
 

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